42 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIRAGE MICRO
FDA 510(k)
FDA Class 2
·Anesthesiology
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
FDA 510(k)
FDA Class 1
·General Hospital
IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 26, 2025
UNKNOWN
FDA Adverse Event
Malfunction
·COOK, INC.·Product code DTK·August 21, 2014
UNK
FDA Adverse Event
Injury
·COOK, INC.·Product code DTK·August 20, 2014
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·August 20, 2014
PINN MAR LIP LNR 32IDX60OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 23, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2011
CAPSURE EPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·July 10, 2008
GUNTHER TULIP VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·April 3, 2026
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·September 12, 2017
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·November 11, 2021
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·December 5, 2017
GUNTHER TULIP VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·November 4, 2025
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·June 4, 2019
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·May 21, 2019
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·March 3, 2017
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·February 22, 2018